Services
- Strategic Planning
- Design nonclinical drug development programs for a variety of drug classes.
- Provide support for all phases of nonclinical drug development activities including toxicology, pharmacokinetics, ADME, and safety pharmacology programs.
- Establish and manage all interactions with contract research organizations (CROs) including:
- Proposal generation
- CRO selection
- Auditing
- Contract set-up
- Study design
- Study monitoring
- Report review
- Prepare nonclinical sections of:
- INDs, NDAs, etc., in Common Technical Document (CTD) format for regulatory filings (e.g., FDA, EMA, Health Canada).
- Investigator’s Brochures
- Interact with regulatory agencies.
- Qualify impurities in drug substances and drug products.
- Provide assistance with government contracts (experience as PI).
- Provide product liability/forensic toxicology support.Having a big sale, on-site celebrity, or other event? Be sure to announce it so everybody knows and gets excited about it.
